Remediation

Problems do arise. Our team will assess, develop a plan, work with the FDA as needed, and help clients implement CAPAs.

Services:

  • FDA Form 483
  • Warning Letter analysis, response, and remediation
  • Clinical site rescue and recovery
  • Internal Gap analysis
  • Create “corrective actions” that are needed for existing quality systems
  • Create tailored training for employees to address gaps
  • Follow up audits